This patent is directed to a barrier assembly for use with a needleless connector, and, in particular, to a barrier assembly for use with a needleless connector wherein the barrier assembly includes a moveable collar and an anti-microbial material.
Intravenous (“I.V.”) therapy involves the delivery of fluids to a patient through a vein. For example, a catheter is placed into the vein of the patient, and then fluids are administered to the patient through the catheter. Typically, the catheter is connected to an administration set in communication with a container, such as a flexible container or bag, from which fluids are infused into the patient.
One way in which the catheter has been attached to the administration set is through the use of needleless connectors. Needleless connectors reduce the risk of accidental sharps injuries to the patient and the healthcare worker. One common type of needleless connector is the Luer-activated valve or device. Another common type is the slit septum, which utilizes a cannula or other non-Luer connector to access the device.
However, because needleless connectors are in direct communication with the patient's vascular system, bypassing the body's natural defenses to microbial invasion, caution must be exercised to prevent device-related bloodstream infections. Bloodstream infections may not only prolong hospital stays, increasing costs, but may cause serious complications for the patient, potentially resulting in death. The likelihood and severity of the infection may be greater given that I.V. therapies are conventionally used with patients whose health is already compromised, and may even be immuno-compromised.
One approach to minimizing contamination has been to employ a recessed valve with a sterile protective cap, which is placed over the valve to prevent microbial contamination. The cap must be replaced with a new sterile cap each time the valve is accessed. Additionally, certain protocols require that the cap be replaced periodically as well. This approach is costly in terms of material and time required, and actually may present additional opportunities for contamination to occur because the caps can become inadvertently contaminated through routine handling, where organisms are transferred from the skin or other contaminated surfaces.
Another approach has been to make the valve flush with the surface to be accessed. The surface may then be disinfected prior to access, typically with isopropyl alcohol, povidone iodine, or chlorhexidine. Proper technique usually requires adequate contact and drying time so as to prevent asepsis. However, proper technique is not always possible, because of the need to administer emergency care on a time critical basis, for example, and because even perfect technique may not reach crevices or interstitial spaces that are difficult or impossible to disinfect.
A still further approach has been to provide a cap that includes a pad soaked in a disinfectant, which cap is detachable from the connector or tethered to the connector by a harness. During times when the connector is not in use, the cap is placed over the valve to prevent contamination. It is suggested that the contact between the pad and the valve causes the valve to be bathed in the disinfectant between uses. However, because the cap is detached from the valve, it remains possible for the cap not to be properly replaced after use of the valve. Further, removal of the cap and its placement on a surface or its dangling from the connector can expose the cap to contamination, such as in the form of colonizing pathogens or general particulate. The colonizing pathogens introduced through inadvertent contamination of the cap may overwhelm the antimicrobial agent, allowing the pathogens to be transferred to the needleless connector. The particulate contamination would not be affected by the antimicrobial agent, and may be transferred to the connector as well.
As set forth in more detail below, the present disclosure sets forth an improved assembly embodying advantageous alternatives to the conventional devices discussed above.